NSPR (NASDAQ:NSPR) Q4 2024 Earnings Conference Call March 12, 2025 8:30 AM ET Company Participants Marvin Slosman - CEO Craig Shore - CFO Shane Gleason - CCO Webb Campbell - IR, Gilmartin Group Conference Call Participants Adam Maeder - Piper Sandler Frank Takkinen - Lake Street Capital Markets Richard Nesbitt - InspireMD Operator Hello and welcome to InspireMD's fourth quarter 2024 earnings conference call. [Operator instructions]. I would now like to turn the call over to Webb Campbell from Gilmartin Grou ...

InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.19 per share versus the Zacks Consensus Estimate of a loss of $0.20. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 5%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.16, delivering a surprise of 20%.Over the last four quarters, the company has surpassed conse ...

Revenue and Profit - Total revenue for Q4 2024 increased by $188,000, or 10.7%, to $1,949,000 compared to $1,761,000 in Q4 2023[4] - For the full year 2024, revenue increased by $804,000, or 13.0%, to $7,009,000 from $6,205,000 in 2023[10] - Gross profit for Q4 2024 decreased by $36,000, or 7.1%, to $469,000, with a gross margin of 24.1%[5][22] - Gross profit for the full year 2024 decreased by $301,000, or 16.7%, to $1,506,000, with a gross margin of 21.5%[11][12] Operating Expenses and Loss - Total operating expenses for Q4 2024 were $9,836,000, an increase of $3,523,000, or 55.8%, compared to $6,313,000 in Q4 2023[7] - Total operating expenses for the full year 2024 were $35,009,000, an increase of $12,059,000, or 52.5%, compared to $22,950,000 in 2023[13] - Net loss for Q4 2024 totaled $9,174,000, or $0.19 per share, compared to a net loss of $5,405,000, or $0.16 per share, in Q4 2023[8][22] - Net loss for the full year 2024 totaled $32,005,000, or $0.76 per share, compared to a net loss of $19,916,000, or $0.82 per share, in 2023[15][22] Cash and Securities - Cash and cash equivalents and marketable securities as of December 31, 2024, were $34,637,000, down from $39,023,000 as of December 31, 2023[9] Liabilities and Equity - Total current liabilities increased to $7,678 million in 2024 from $6,020 million in 2023, representing a 27.5% increase[25] - Total long-term liabilities rose to $3,043 million in 2024, up from $2,122 million in 2023, marking a 43.4% increase[25] - Total liabilities reached $10,721 million in 2024, compared to $8,142 million in 2023, reflecting a 31.7% increase[25] - Total equity decreased to $36,086 million in 2024 from $39,501 million in 2023, a decline of 8.9%[25] - Additional paid-in capital increased to $289,589 million in 2024, up from $261,000 million in 2023, showing an increase of 11%[25] - The accumulated deficit widened to $(253,506) million in 2024 from $(221,501) million in 2023, indicating a deterioration of 14.5%[25] - The number of common shares issued and outstanding increased to 26,611,033 in 2024 from 21,841,215 in 2023, a growth of 21.9%[25] - Total liabilities and equity amounted to $46,807 million in 2024, down from $47,643 million in 2023, a decrease of 1.8%[25] Lease and Employee Liabilities - Operating lease liabilities increased to $1,796 million in 2024 from $1,038 million in 2023, representing a 73.2% increase[25] - Liability for employee rights upon retirement and others rose to $1,247 million in 2024, up from $1,084 million in 2023, a 15.1% increase[25] Future Prospects - The company anticipates a potential U.S. launch of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval[3][6]

Management to host investor conference call today, March 12th, at 8:30am ETMIAMI, March 12, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the fourth quarter and full year ended December 31, 2024. Recent Business Highlights: Engaged with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application fo ...

Revenue and Profitability - For the twelve months ended December 31, 2024, revenue increased by $804,000, or 13.0%, to $7,009,000 from $6,205,000 in 2023, driven by growth in existing and new markets[323]. - Gross profit decreased by 16.7%, or $301,000, to $1,506,000, with gross margin dropping to 21.5% from 29.1% in 2023, primarily due to a $1,105,000 increase in cost of goods sold[325]. - Net loss rose by $12,089,000, or 60.7%, to $32,005,000 for the twelve months ended December 31, 2024, driven mainly by a $12,059,000 increase in operating expenses[332]. Expenses - Research and development expenses increased by 70.8%, or $5,653,000, to $13,634,000, mainly due to increased compensation and costs associated with the development of SwitchGuard NPS and clinical trials[326]. - Selling and marketing expenses rose by 57.0%, or $2,204,000, to $6,069,000, driven by increased compensation expenses as the company builds its commercial sales force in anticipation of FDA approval[328]. - General and administrative expenses increased by 37.8%, or $4,202,000, to $15,306,000, primarily due to a rise in share-based compensation and salary expenses[329]. Market and Product Development - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated to be approximately $1.3 billion, with a total available market of approximately $9.3 billion assuming full penetration[314]. - The C-GUARDIANS trial enrolled 316 patients across 24 trial sites, with a 30-day DSMI rate of 0.95% and a one-year follow-up rate of 1.95%[311]. - The company received FDA approval for the IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System in October 2024[312]. - The company is seeking strategic partners for the potential launch of CGuard EPS in Japan and other Asian countries following its CE mark recertification in January 2024[308]. Financial Position - Cash and cash equivalents were $18,916,000 and marketable securities were $15,721,000 as of December 31, 2024, compared to $9,640,000 and $29,383,000 respectively in 2023[338]. - Net cash used in operating activities increased by $5,492,000 to $21,868,000 for the twelve months ended December 31, 2024, from $16,376,000 in 2023[339]. - Cash provided by financing activities was $18,452,000 for the twelve months ended December 31, 2024, down from $37,534,000 in 2023, with the primary source being proceeds from warrant exercises[341]. - The company had an accumulated deficit of $254 million as of December 31, 2024, and expects to continue incurring losses and negative cash flows until the product CGuard EPS reaches commercial profitability[333]. - The company raised approximately $42.2 million from a Private Placement Offering in May 2023, with potential additional proceeds of $71.4 million if warrants are fully exercised[335]. - The company entered into an Equity Distribution Agreement allowing for the sale of up to $17 million in common stock, with $2,199,395 raised as of the report date[337]. Future Outlook - Future operating results may be affected by various factors, including regulatory approvals, clinical trial phases, and economic conditions impacting customer demand[344]. - The total future payments for operating lease obligations were approximately $2,939,000 as of December 31, 2024[342].

Core Viewpoint - InspireMD, Inc. is set to release its fourth quarter and full year 2024 financial results on March 12, 2025, and will host a conference call to discuss these results and recent highlights [1]. Company Information - InspireMD, Inc. develops the CGuard™ Prime carotid stent system aimed at treating carotid artery disease (CAD) and preventing strokes [1]. - The company utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, focusing on achieving excellent acute results and long-term, stroke-free outcomes [3]. - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR [3]. Investor Relations - Interested parties can access the live earnings call via telephone or through a webcast available on the InspireMD investor relations website [2]. - A replay of the webinar will be available shortly after the call and will be archived on InspireMD's website [2]. - Investor contact information includes Craig Shore, Chief Financial Officer, and Webb Campbell from Gilmartin Group LLC [4].

Company Overview - InspireMD Inc. (NSPR) has announced the first patient enrollment in the CGUARDIANS II clinical trial, which evaluates the CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach [1][2] - The CGuard Prime Carotid Stent is designed to prevent strokes in patients with carotid artery disease, utilizing proprietary MicroNet technology for embolic protection [5][8] - The company currently has a market capitalization of $81.64 million [4] Clinical Trial Details - CGUARDIANS II is a prospective, multi-center, single-arm pivotal study aiming to enroll at least 50 evaluable patients to assess the acute device success and technical success of the CGuard Prime in conjunction with an FDA-cleared TCAR neuro-protection system [2] - The trial has shown positive clinical outcomes, with a major adverse event rate of 1.95% over a one-year follow-up, the lowest reported for any carotid stent or embolic protection device in a pivotal trial [7] Regulatory Approval and Market Potential - In October, the company received FDA premarket approval for the CGuard Prime Carotid Stent System, allowing it to market the device in the U.S. for treating carotid artery stenosis [6][9] - The global carotid artery stents market was valued at $559.7 million in 2021 and is expected to grow at a CAGR of 3.0% from 2022 to 2030, driven by the rising prevalence of cardiovascular diseases [10] Stock Performance - Following the announcement of the clinical trial, NSPR shares closed flat at $3.14, with an 11.7% gain year-to-date compared to the industry’s 6.4% growth [3]

Company Overview - InspireMD, Inc. is focused on developing the CGuard™ Embolic Prevention Stent System (EPS) aimed at preventing strokes [1][3] - The company utilizes proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing outstanding acute results and durable, stroke-free long-term outcomes [3] Leadership Appointment - Scott R. Ward has been appointed to the Board of Directors, bringing extensive experience in the medical technology sector, particularly in cardiovascular health [1][2] - Ward previously served as CEO and President of Cardiovascular Systems, Inc. before its acquisition by Abbott in April 2023 [1][2] - His addition is expected to provide valuable insights as the company approaches potential U.S. approval of CGuard Prime, which is seen as a significant value inflection point for InspireMD [2] Strategic Goals - The company aims to advance its carotid platform and innovate its pipeline, including CAS, TCAR, and Neuro focuses, under Ward's guidance [2] - Ward believes that upon U.S. approval, CGuard will become a new standard of care for carotid intervention and stroke prevention, highlighting the strong data supporting its efficacy [2]

Financial Data and Key Metrics Changes - Total CGuard revenue for Q3 2024 was $1.81 million, representing a growth of over 16% compared to Q3 2023 [7][25] - Gross profit decreased by $24,000, or 5.6%, to $414,000, with gross margin decreasing to 22.9% from 28.1% year-over-year [26] - Total operating expenses increased by $2.8 million, or 46.1%, to $8.9 million compared to Q3 2023 [27] - Net loss for Q3 2024 totaled $7.9 million, or $0.16 per share, compared to a net loss of $5.2 million, or $0.15 per share in Q3 2023 [29][30] - Cash, cash equivalents, and marketable securities were $40.4 million as of September 30, 2024, compared to $39 million at the end of 2023 [30] Business Line Data and Key Metrics Changes - Sales of over 3,100 CGuard implants during Q3 2024 represented growth of nearly 14% year-over-year [7] - CGuard technology has captured double-digit market share across 30 countries, with over 60,000 implants sold to date [8] Market Data and Key Metrics Changes - If the 3,129 implants sold internationally during Q3 had been sold in the U.S., they would have generated over $14 million in revenue [9] - The current U.S. TCAR market leader reported about $49 million in revenue on 6,700 procedures last quarter, indicating significant potential for CGuard in the U.S. market [10] Company Strategy and Development Direction - The company anticipates the approval and launch of CGuard Prime in the U.S. in the first half of 2025, which is expected to drive significant revenue growth [11] - A PMA premarket approval application was submitted to the FDA, with a decision anticipated in early 2025 [12] - The company is investing in building a world-class commercial and operational engine to support the U.S. launch [17] - A strategic agreement was announced with the Jacobs Institute to conduct an early feasibility study of CGuard Prime for severe carotid stenosis [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting supply demands through contract manufacturing and internal production strategies [33] - The company is focused on targeting interventional cardiologists and neurointerventionalists for initial U.S. sales efforts [37][41] - Management highlighted the importance of physician enthusiasm for the product, indicating a strong interest from trial sites [40] Other Important Information - The company has established a new headquarters in Miami, Florida, to support its U.S. operations [17] - The FDA accepted the PMA submission effective September 15, 2024, triggering a 180-day review period [13] Q&A Session Summary Question: Update on U.S. sales force hiring and transition to new headquarters - Management expressed excitement about the new Miami facility and the interest from top talent in the industry [32] - Plans are in place to meet supply demands through various strategies, including contract manufacturing [33] Question: U.S. commercial strategy and targeted accounts - Initial focus will be on interventional cardiologists and neurointerventionalists for carotid stenting procedures [37][41] Question: CGuardians II trial design and SwitchGuard product features - CGuardians II IDE study is approved, with expectations for first enrollments before the end of the year [44] - Focus on usability and deliverability for the SwitchGuard product, with positive early feedback from vascular surgeons [45][46]

Company Performance - InspireMD, Inc. reported a quarterly loss of $0.16 per share, better than the Zacks Consensus Estimate of a loss of $0.20, and compared to a loss of $0.15 per share a year ago, representing an earnings surprise of 20% [1] - The company posted revenues of $1.81 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.02%, and compared to year-ago revenues of $1.56 million [2] - Over the last four quarters, InspireMD has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - InspireMD shares have lost about 12.6% since the beginning of the year, while the S&P 500 has gained 25.8% [3] - The current consensus EPS estimate for the coming quarter is -$0.20 on $1.83 million in revenues, and for the current fiscal year, it is -$0.82 on $6.83 million in revenues [7] - The estimate revisions trend for InspireMD is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which InspireMD belongs, is currently in the top 27% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]